Building Blocks - a trial of home visits for first time mothers
| ISRCTN | ISRCTN23019866 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23019866 |
| Secondary identifying numbers | Version 1.4 |
- Submission date
- 24/03/2009
- Registration date
- 20/04/2009
- Last edited
- 29/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mike Robling
Scientific
Scientific
Director South East Wales Trials Unit
Department of Primary Care and Public Health
7th Floor Neuadd Meirionnydd
Cardiff University
Heath Park
Cardiff
CF14 4YS
United Kingdom
Study information
| Study design | Individually randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluating the family nurse partnership programme in England: a randomised controlled trial |
| Study acronym | Building Blocks |
| Study objectives | The purpose of this study is to see if providing young first time mothers with extra support before and after the birth is helpful for both mother and child. We are specifically interested in whether the programme makes a difference to the mother and baby's health and behaviour: 1. During pregnancy and at birth 2. In the first two years after birth |
| Ethics approval(s) | Research Ethics Committee (REC) for Wales, 17/02/2009, ref: 09/MRE09/08 |
| Health condition(s) or problem(s) studied | First-time pregnancy |
| Intervention | This trial will assess the effectiveness of the FNP in England compared with existing universal services, in achieving its stated objectives (namely, to improve pregnancy outcomes, child health and development and parents' economic self-sufficiency). The trial will start after consent and recruitment into the trial. Participants will be recruited into the trial as soon as the pregnancy is confirmed but before 24 weeks gestation. Participants will be randomised to either entry into the FNP programme arm or to the control arm (universal services), and will be followed up until 2 years after the birth of the child. The whole trial will last 52 months. Interviews (either face-to-face or by telephone) for both arms of the trial will be at baseline, 34 - 36 weeks gestation and 6, 12, 18 and 24 months after birth. If participants are selected to join the group that receives the FNP programme, they will receive visits from a specially trained 'Family Nurse'. The Family Nurse would normally go to the participants' home, but can see you somewhere else if they prefer. The Family Nurse will visit the participant every week for the first month after they join the study, and then every other week until the baby is born. The Family Nurse will then visit the participant weekly until the baby is six weeks old and then once every two weeks until the child is 20 months old. The last four visits are monthly until the child is 2 years old. |
| Intervention type | Other |
| Primary outcome measure | 1. Changes in prenatal tobacco use (maternal measure), measured at baseline and 34 - 36 weeks gestation interviews 2. Birth weight (child measure), measured at birth (collected afterwards) 3. Emergency attendances/admissions within two years of birth, measured at all timepoints 4. Proportion of women with a second pregnancy within two years of first birth, measured at all timepoints |
| Secondary outcome measures | 1. Intention to breastfeed 2. Prenatal attachment 3. Injuries and ingestions 4. Breastfeeding (initiation and duration) 5. Language development 6. Education 7. Employment 8. Income/benefits 9. Home (tenure) 10. Health status 11. Self-efficacy 12. Social support 13. Paternal involvement Timepoints not finalised as of 24/03/2009. |
| Overall study start date | 06/04/2009 |
| Completion date | 19/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1600 |
| Total final enrolment | 1645 |
| Key inclusion criteria | 1. Women aged 19 years or under (at recruitment/consent) 2. Lives within the catchment area covered by the local family nurse partnership (FNP) team 3. First pregnancy confirmed by health services (including those expecting multiple birth) unless previous pregnancy ended in miscarriage, stillbirth or termination 4. Recruited no later than 24 weeks 5. Gillick competent to provide adequate informed consent to research participation including competence in English at conversational level or higher |
| Key exclusion criteria | 1. Women who at study entry, plan to have their child adopted 2. Women who at study entry, plan to leave the FNP area during the time of the trial either for an extended period of time (3 months or longer) or permanently 3. Women who would require a third person (translator, sign interpreter) to receive the FNP programme |
| Date of first enrolment | 25/06/2009 |
| Date of final enrolment | 28/07/2010 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
South East Wales Trials Unit (SEWTU)
Institute of Primary Care and Public Health
Cardiff University
7th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Cardiff University
7th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Policy Research Programme
Research and Development Directorate
NIHR CCF PO Box 407
Teddington, Middlesex
Teddington
TW11 0XX
United Kingdom
| Website | http://www.dh.gov.uk/en/index.htm |
|---|---|
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
Department of Health (UK) (ref: 006/0060) - Policy Research Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/08/2013 | Yes | No | |
| Results article | results | 09/01/2016 | Yes | No | |
| Results article | results | 20/09/2016 | Yes | No | |
| Results article | results | 05/05/2018 | 14/05/2019 | Yes | No |
| Other publications | analysis | 30/12/2019 | 02/01/2020 | Yes | No |
| Other publications | economic evaluation | 13/09/2019 | 04/06/2020 | Yes | No |
| Results article | 23/09/2022 | 29/09/2022 | Yes | No |
Editorial Notes
29/09/2022:Publication reference added.
04/06/2020: Publication reference added.
02/01/2020: Publication reference added.
14/05/2019: Publication reference and total final enrolment added.
26/06/2016: publication reference added.
13/01/2015: the following changes were made to the trial record:
1. The overall trial end date was changed from 31/01/2013 to 19/09/2014.
2. The target number of participants was changed from 2400 to 1600.
